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Regulations

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05Feb 2024
EU, Regulations Cubicdesignz Comments: 0

Electronic Instructions For Use Of Medical Devices

Commission Regulation (EU) No 207/2012 on electronic instructions for use of medical devices was published on 9 March 2012 and came into effect on 1 March 2013. There are 10 articles in this regulation. It establishes certain requirements for the “instructions for use” for the user that must be noted by the manufacturer of the device, to ensure proper and safe use of the device as well as to know about the precautions while using the device. It is meant to reduce potential risks as much...
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05Feb 2024
EU, Blogs, Regulations Cubicdesignz Comments: 0

EU Requirements for Translations

Under the Medical Devices Directive (MDD), it is required that manufacturers have translations of the technical documents like Instructions for Use. However, this rule wasn’t strictly followed up until MDR was brought in place. The European Union’s language requirements information can be found in Article 41 and Annex 1 (Chapter 3) of the EU MDR. Language requirements: EU Requirements for Translations As per MDR 2017/745, the information provided with medical devices needs to be tr...
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05Feb 2024
EU, Regulations, Swiss, UK Cubicdesignz Comments: 0

UDI DI

UDI-DI On 5 May 2017, the EU published the new EU MDR 2017/745 and IVDR 2017/746 regulations in which they formally introduced the UDI system in the EU. The UDI comprises the following components The Basic UDI-DI is a technique introduced by the EU for linking medical devices to their regulatory documentation so that the model of the product can be uniquely identified throughout its entire lifecycle. The linked documentation may include the declaration of conformity, notified body certificates,...
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05Feb 2024
EU, Regulations Cubicdesignz Comments: 0

In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746

The IVD medical devices Regulation (EU) 2017/746 (IVDR) brings EU legislation into line with technical advances, changes in medical science, and progress in law-making. The new Regulation creates a robust, transparent, and sustainable regulatory framework recognised internationally, improving clinical safety and creating fair market access for manufacturers.  In contrast to the previous Directive, the new Regulation is directly applicable and does not need to be transposed into na...
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05Feb 2024
Regulations Cubicdesignz Comments: 0

Classification of Medical Devices Based on UK MDR 2002

The classification of medical devices in the UK market will be based on UK MDR 2002 from 1st January 2021. Medical devices are classified into a particular class based on the level of risk they pose to the patient and according to the intended purpose of use. The medical devices are classified based on the classification rules in Annex IX of Directive 93/42 into one of the following four classes: The medical devices are classified into the above-given classes based on 18 rules men...
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05Feb 2024
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Switzerland Authorised Representative

Medical devices are regulated by: the Swiss Agency for Therapeutic Product Manufacturer Responsibility Mutual Recognition Agreement (MRA) between EU and Switzerland: Possible situations Depending on the terms of MRA, this situation will exempt the manufacturer from EU member states from the Swiss Authorized Representative(AR) requirement. European AR will be accepted as same as Swiss ARs and vice versa. Manufacturers outside the EU and Switzerland will still ne...
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05Feb 2024
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EU Authorised Representative

Responsibilities of EU Authorised Representative • When a device manufacturer is established outside of the European Union, the manufacturer needs to appoint an authorised representative to place the medical device in one of the member states. An Authorized Representative is any person naturally or legally established in the European Community who can act on behalf of the manufacturer. • A written mandate/letter designating an authorised representative for a medical device manufacturer is ma...
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05Feb 2024
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UK Medical Device Regulation

UK Medical Device Regulations UK Medical Device Regulation Role of MHRA UK Approved Bodies UK Approved Notified Bodies Update from NB’s Manufacturers Authorised Representatives Importer & Distributor Registrations in Great Britain Registration Timeline – UK Registration Data • Copy of Declaration of Conformity• E-copy of technical documentation• Device Certificate as granted by the Notified Body• Quality Management Certificate• Database information Manufacturing details• Lett...
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05Feb 2024
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Switzerland Medical Device Regulations

Switzerland Market Situation Switzerland Market Situation – Downside Switzerland- Medical Device Regulations Medical devices are regulated by: the Swiss Agency for Therapeutic Product Manufacturers Outside Swiss – Proxy to the foreign manufacturer – Responsible for product safety – Liable for product defects – contact person for Swiss authorities – can be a legal entity or a natural person – must have access to PRRC Roles of Swiss AR’s PRRC Liability of a Swiss AR Manufacturer Re...
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05Feb 2024
Blogs, EU, Regulations Cubicdesignz Comments: 0

EU MDR – Language Requirements  

October 2021.   The EU MDR 2017/745 brings more safety to the device in the European market. As part of the Safety measure for the largest medical device market in the world EU Union has made measures to make sure the product sold in the EU market is accessible for everyone at the same time is safe and traceable at every stage of the product lifecycle. The new regulation has made measure that a professional user as well as a lay person can understand the correct usage of the devic...
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